Metabolism and nutrition disorders: Hyperkalaemia in patients with Chronic Kidney Disease CKD with HK
Conditions
Interventions
All participants will be treated with SZC as per local label (correction and
maintenance treatment) during the in-hospital phase. The duration of
in-hospital phase will be 2 to 21 days post-enrolmen
medical monitor*s
approval may be sought for allowing longer duration hospital stays for specific
participants.
At discharge, participants who are NK (K+ between 3.5 and 5.0 mmol/L,
inclusive) and
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1 Must be 18 years of age or older, at the time of signing the informed consent 2 Admitted to hospital (inpatient care; directly or from ED) 3 With: - diagnosed CKD (any stage) or - eGFR = 3.> 5.0 and
Exclusion criteria
Exclusion criteria: 1 Hospitalisation for an acute cardiovascular event within 12 weeks prior to screening 2 Unable to take oral SZC drug mix 3 - 4 With a life expectancy of less than 6 months 5 Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant not suitable for inclusion 6 QT interval corrected by the Fridericia method (QTcF) > 550 msec 7 History of QT prolongation associated with other medications that required discontinuation of that medication 8 Congenital long QT syndrome 9 Clinically significant arrythmias as judged by the investigator 10 Ongoing treatment with SZC or patiromer before current ED visit/hospital admission (ongoing treatment with other K-binders before current ED visit/hospital admission is allowed). Note: Initiation of SZC or patiromer during the current ED visit/hospitalisation preceding enrolment is allowed. 11 Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled date for a kidney transplant. Note: Emergency/unscheduled haemodialysis to treat HK during the current ED visit/hospitalisation preceding enrolment is allowed. 12 Participation in another clinical study with an investigational medical product (IMP) administered during the month before screening. 13 Known hypersensitivity to SZC or any of the excipients of the product 14 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 15 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements 16 Previous randomisation in the present study 17 For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not postmenopausal) who are not willing to use one of the methods of contraception described hereafter, or who are not stable on the contraception method for the last one month, from the time of signing the informed consent throughout the study and 7 days after the last dose (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (c) Intrauterine device (d) Intrauterine hormone-releasing system (e) Bilateral tubal occlusion (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. 18 For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Endpoint: Occurrence (yes/no) of NK (K+ between 3.5 and 5.0 mmol/L, inclusive) at 180 days post-discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Endpoint: Time to first occurrence of all-cause hospital admissions or ED visits with HK as a contributing factor, use of rescue therapy for HK, or all-cause death at any time post-discharge up to 180 days. 2. Endpoint: Time to first occurrence of any component of all-cause hospital admission or ED visit, both with HK as a contributing factor, at any time post-discharge up to 180 days. 3. Endpoint: Number of all-cause hospital admission or ED visit both with HK as a contributing factor, at any time post-discharge up to 180 days.. 4. Endpoint: Time to first occurrence of RAASi down-titration (including discontinuation) at any time post-discharge up to 180 days. 5. Time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor at any time post-discharge up to 180 days. 6. Number of hospital admission or ED visits, both with HK as a contributing factor at any time post discharge up to 180 days. | — |
Countries
Netherlands
Outcome results
None listed